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C-RFA of Residual Limb Neuroma

NCT04538417 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-01-08

Study results available
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Summary

To assess changes in pain, physical function, and health-related quality of life in patients with post-amputation neuroma-associated residual limb pain after cooled radiofrequency ablation.

Conditions

  • Phantom Limb Pain
  • Neuroma Amputation

Interventions

DEVICE

Cooled Radiofrequency Ablation

RFA procedures will be performed with modification accounting for appropriate C-RFA technique. Participant will be positioned prone and skin prepped with chloroprep. Ultrasound probe will be placed on residual limb at a transverse angle in order to view the nerve and associated neuroma in long-axis. The probe will be advanced to the site of the stump neuroma. C-RFA electrode will be placed adjacent to neuroma. Needle will be connected via wire to a cooled radiofrequency generator. Motor and sensory testing will be performed to reproduce or exacerbate the RLP and / or PLP. At the site of the neuroma, 2 mL of local anesthetic will be injected through the needle. C-RFA lesions will be created by using the typical C-RFA protocol. Upon completion needle will be removed. Following ablation, 0.5 mL of 0.5% bupivacaine will be injected at the site of the ablated neuroma to provide post procedure analgesia.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-27
Primary Completion
2023-08-30
Completion
2023-08-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04538417 on ClinicalTrials.gov